Abstract: Objective To investigate the causes and characteristics of serious adverse drug reaction (ADR)/adverse event (AE) that occurred in the First Affiliated Hospital of Xi'an Jiaotong University along with literature research so as to provide reference for clinical rational, safe and effective drug use. Methods The clinical data on 140 cases of serious ADR/AE was collected between January 2016 and June 2019 in the hospital. The patients' age, gender, types of drugs, systems-organs involved, adverse manifestations and routes of administration were statistically analyzed. Results The ratio of male patients to female ones was 1.17:1 and the incidence of ADR/AE was the highest among patients over 50 years old (68.57%). The drugs involved were mainly anti-tumor (42.86%) and anti-infective (24.29%) drugs. There were 13 anti-tumor drugs and 2 antimicrobial drugs among the top 15 drugs, and voriconazole was responsible for more ADR cases than any of the other drugs. The main clinical manifestation was blood system damage. The incidence of ADR related to intravenous infusion was the highest, accounting for 59.28%. Conclusion Clinicians should be more cautious with the medication for middle-aged and elderly patients and with the usage of anti-tumor and antimicrobial drugs. Post-medication monitoring and guidance of clinical pharmacists should be put in place in order to reduce or prevent the occurrence of ADR/ AE and ensure the safety of patients' medication.

Key words: severe adverse drug reactions/events, report analysis, drug safety